Catheter wetting system and method

ABSTRACT

The present invention includes a system and method for wetting a catheter. The wetting system can include a catheter container, a fluid packet, and a catheter. The fluid packet and catheter container are adapted and configured to require opening the packet and moving the container to wet the catheter. The method includes opening the packet and moving the container to wet the catheter.

FIELD OF THE INVENTION

[0001] The present invention includes a system and method for wetting acatheter. The wetting system can include a catheter container, a fluidpacket, and a catheter. The fluid packet and catheter container areadapted and configured to require opening the packet and moving thecontainer to wet the catheter. The method includes opening the packetand moving the container to wet the catheter.

BACKGROUND OF THE INVENTION

[0002] Wetting of wettable catheters, such as hydrophilic urinarycatheters, produces lubrication that is advantageous for insertion intothe urethra. The lubrication is increases the comfort of thecatheterized subject and eases insertion of the catheter. Inserting adry or incompletely wetted catheter can be painful.

[0003] Wettable catheters, particularly hydrophilic urinary catheters,can be wetted by a variety of methods. For example, the catheter can beremoved from its package and wetted. Such a method of wetting riskscontaminating the catheter. Alternatively, some catheters are packagedwith a container of fluid and opening the fluid container is sufficientto wet the insertable length of the catheter. Such a package iscomplicated and requires a large volume of fluid, which must be disposedof.

[0004] There remains a need for additional systems and methods forwetting wettable catheters.

SUMMARY OF THE INVENTION

[0005] The present invention includes a system and method for wetting acatheter. The wetting system can include a catheter container, a fluidpacket, and a catheter. The fluid packet and catheter container areadapted and configured to require opening the packet and moving thecontainer to wet the catheter. The method includes opening the packetand moving the container to wet the catheter.

[0006] In an embodiment, the wetting system includes a cathetercontainer adapted and configured to enclose the fluid packet and thecatheter. The fluid packet is adapted and configured to be opened and torelease fluid without opening the catheter container. The fluid packetis adapted and configured to be squeezed, pressed, or struck to releasefluid. The fluid packet and the catheter container are adapted andconfigured so that mere release of fluid from the fluid packet onlyincompletely wets the catheter. Mere release of fluid from the packetdoes not wet the catheter to an extent sufficient to render the catheterinsertable. The system is adapted and configured for movement ormanipulation of the container to wet the catheter to an extent that itcan be inserted.

BRIEF DESCRIPTION OF THE DRAWINGS

[0007]FIG. 1 schematically illustrates an embodiment of the presentsystem including a catheter pouch, a fluid packet, and a wettablecatheter.

[0008]FIG. 2 schematically illustrates the embodiment of FIG. 1, inwhich the fluid has been released from the packet, but the pouch has notbeen moved.

[0009]FIG. 3 schematically illustrates the embodiment of FIG. 2, inwhich the pouch has been moved to wet the coated surface of the wettablecatheter.

[0010]FIG. 4 schematically illustrates an embodiment of the presentsystem including a catheter pouch in the form of a segmented catheterpouch, a fluid packet, and a wettable catheter.

[0011]FIG. 5 schematically illustrates the embodiment of FIG. 4, inwhich the fluid has been released from the packet, but the pouch has notbeen moved.

[0012]FIG. 6 schematically illustrates the embodiment of FIG. 5, inwhich the pouch has been moved to wet the coated surface of the wettablecatheter.

DETAILED DESCRIPTION OF THE INVENTION

[0013] Definitions

[0014] As used herein, the phrase “hydrophilic catheter” refers to acatheter on which the shaft and tip have a hydrophilic surface that whenwet that provides advantageous lubrication during insertion and use ofthe hydrophilic catheter.

[0015] As used herein, the phrase “hydrophilic urinary catheter” refersto a hydrophilic catheter sized and constructed for occupying amammalian urethra and draining a mammalian bladder.

[0016] As used herein, the phrase “insertable length” of a hydrophilicurinary catheter refers to the length of the catheter shaft that iscoated with the hydrophilic material and inserted into the subject'surethra. For a human female subject, the insertable length is about80-140 mm. For a human male subject, the insertable length is about200-350 mm.

[0017] As used herein, the phrases “only incompletely wets”,“incompletely wetting”, and like phrases refer to wetting less than theinsertable or inserted length of the catheter and/or not wetting theinsertable or inserted length of the catheter to a sufficient extent torender it insertable into a human urethra without unacceptablediscomfort. For example, the entire insertable length of the cathetercan be wetted, but not wetted to a sufficient extent to render itinsertable. Wetting to a sufficient extent requires contact withsufficient wetting fluid to wet the catheter for a sufficient time towet the catheter. For example, a wettable catheter can include a coatingthat requires wetting for insertion of the catheter. Each unit volume ofthe coating can require contact with sufficient wetting fluid to wetthat entire coating volume. Each unit volume of the coating can requirecontact with wetting fluid for sufficient time for the wetting fluid towet that entire coating volume. For example, contact with visible liquidwater for about 10, about 20, to 30 seconds or more can wet the coatingon a hydrophilic urinary catheter.

[0018] Catheter Wetting System and Method

[0019] The present invention relates to a system and method for wettinga catheter. The system can include a catheter, a catheter container, anda fluid packet. The system can be employed in the method of theinvention.

[0020] Catheters suitable for the system and method include cathetersthat benefit from wetting before use, for example, before insertion intoa subject. Such a catheter is referred to herein as a wettable catheter.Wettable catheters include hydrophilic catheters, such as hydrophilicurinary catheters.

[0021] In the present system and method, the catheter container and thefluid packet are configured so that opening the fluid packet in thecatheter container only incompletely wets the catheter. For example, thecatheter container can be configured so that fluid does not move readilyalong the length of the catheter unless the catheter container is moved.For example, the catheter can be positioned within the cathetercontainer so that fluid does not move readily along the length of thecatheter unless the catheter container is moved. For example, the fluidpacket can contain an amount of fluid that does not readily move alongthe length of the catheter unless the catheter container is moved. Forexample, the fluid packet can be positioned so that fluid that does notreadily move along the length of the catheter unless the cathetercontainer is moved.

[0022] For example, the catheter container can be configured so that itmust be moved to contact the catheter with sufficient wetting fluid fora sufficient time to completely wet the catheter. For example, thecatheter can be positioned within the catheter container so that thecontainer must be moved to contact the catheter with sufficient wettingfluid for a sufficient time to completely wet the catheter. For example,the fluid packet can contain an amount of fluid so that the containermust be moved to contact the catheter with sufficient wetting fluid fora sufficient time to completely wet the catheter. For example, the fluidpacket can be positioned within the catheter container so that thecontainer must be moved to contact the catheter with sufficient wettingfluid for a sufficient time to completely wet the catheter.

[0023] For example, the catheter container can be configured so that itmust be moved to contact the insertable length of the catheter withwetting fluid. For example, the catheter can be positioned within thecatheter container so that the container must be moved to contact theinsertable length of the catheter with wetting fluid. For example, thecatheter can be positioned within the catheter container so that thecontainer must be moved to contact the insertable length of the catheterwith wetting fluid. For example, the fluid packet can contain an amountof fluid so that the container must be moved to contact the insertablelength of the catheter with wetting fluid. For example, the fluid packetcan be positioned within the catheter container so that the containermust be moved to contact the insertable length of the catheter withwetting fluid.

[0024] The present catheter container can have a configuration and canbe constructed of material suitable for enclosing a catheter and a fluidpacket. The catheter container has a configuration and/or constructionsuitable for moving the container to move fluid within the containerover the length of the catheter. The catheter container can be adaptedand configured to be moved in any of a variety of ways including movingthe container through space (e.g., rotating, tipping, or waving thecontainer), moving a portion of the container (e.g., bending thecontainer), or manipulating the container (e.g., pushing wetting fluid,material making up the container, or contents of the container). Forexample, the catheter container can be sufficiently small and light thatit can be tipped or twisted to move water over the length of thecatheter. For example, the catheter container can be made of flexiblematerial that can be manipulated to move fluid over the length of thecatheter.

[0025] In an embodiment the catheter container has a configuration of anelongated sheath, pouch, envelope, pocket, or the like. In an embodimentthe catheter container, can be formed from material that provides a viewof the catheter against an opaque or translucent background. Forexample, the catheter container can be formed from a sheet oftransparent material and a sheet of opaque or translucent material. Thesheets can be bonded together around the perimeter of a cavitycontaining the catheter and the fluid packet. For example, the cathetercontainer can be in the form of a pouch formed from a translucentmaterial and a clear material, a first side of the pouch comprising thetranslucent material and a second side of the pouch comprising the clearmaterial. Such a pouch can be sealed around the edges.

[0026] In an embodiment, the catheter is loose within the cathetercontainer. In an embodiment, the catheter is removably positioned withincatheter container. Similarly, in an embodiment, the fluid packet isloose within the catheter container. In an embodiment, the fluid packetis fixedly positioned within the catheter container. In an embodiment,the fluid packet is removably positioned within the catheter container.In an embodiment, the fluid packet is a compartment formed from thematerial of the catheter container.

[0027] The present fluid packet can have a configuration and can beconstructed of material suitable for containing fluid in a cathetercontainer. The fluid packet can be configured for containing sufficientfluid to completely wet the catheter with movement of the cathetercontainer, but to only incompletely wet the catheter without movement ofthe catheter container. The fluid packet can be configured for releasingfluid upon application of a force to the packet without opening thecatheter container. For example, the fluid packet can include a fluidfilled cavity bounded by two pieces of material bonded with a seam.Squeezing or striking such a fluid packet can breach the material or theseam and release the fluid. The material or seam can be substantiallyuniform around the edge.

[0028] The fluid packet can take any of a variety of forms, such as asachet, an ampoule, a tube, or the like. The fluid packet can be made ofany of a variety of materials such as aluminum foil, poly(vinylidenechloride), metallized film, or the like. The metallized film can be orinclude metallized poly(ethylene terephthalate). Preferably, the fluidpacket is made from a hydrophobic material, such as a hydrophobicplastic, such as polyethylene or material including polyethylene. Thefluid packet can include a first piece of packet material and a secondpiece of packet material. In this configuration, the first piece andsecond piece of packet material can be sealed to one another around theedges. The seal can be substantially uniform around the edge.

[0029] The fluid packet can contain any of a variety of fluids suitablefor wetting a catheter. In an embodiment, the fluid is an aqueouswetting composition. The aqueous wetting composition can be any of avariety of aqueous wetting compositions suitable for wetting a catheter,such as a hydrophilic catheter. The aqueous wetting composition can beor include a sterile composition, such as sterile water (e.g. tap,deionized, or distilled water), sterile saline solution, or the like. Inan embodiment, the aqueous wetting composition is or is made fromdistilled water.

[0030] In an embodiment, the fluid packet is of a volume that providesinsufficient fluid for completely wetting the catheter without moving ormanipulating the catheter container. For example, the fluid packet canhave a volume of about 10-15 mL in a much larger container.Advantageously, such a low-volume fluid packet can provide for lesswater that might be spilled during use of the catheter and/or disposalof the used container, less wastewater, and/or less mass and volume topackage and transport.

[0031] The present system can include any of a variety of componentsuseful with the catheter. For example, the added component can be usefulfor inserting, using, removing, or disposing of the catheter. Thepresent system can include a urine collection bag. The present systemcan include instructions about the use of the system or any part of thesystem. Such instructions, for example, can state that the cathetercontainer be moved to move the wetting fluid over the insertable coatedlength of the catheter. Such instructions can be printed on the cathetercontainer or on an instruction sheet included with the system. Anarticle of manufacture can include the system plus one or more of theseadditional components.

[0032] The Method

[0033] The present invention relates to a method for wetting a catheter.The method can include providing a catheter and a fluid packet in acatheter container, breaching the fluid packet to release fluid into thecontainer thereby only incompletely wetting the catheter, and moving thecontainer to wet the catheter. The method can include providing thesystem of the invention. In an embodiment, providing includes providinga catheter container with the catheter and the fluid packet sealedinside.

[0034] The method can include breaching the fluid packet to release thefluid by any of a variety of mechanisms or conditions suitable forreleasing fluid from a fluid packet inside a container, such as acatheter container. Breaching can be accomplished by a health careprofessional or by a person who will be using the catheter. In anembodiment, breaching can be accomplished by a person with diminishedstrength, coordination, or manual dexterity. Breaching can include, forexample, striking, piercing, or squeezing the fluid packet. Preferably,breaching includes, for example, striking, piercing, or squeezing thefluid packet without opening the catheter container. For example,breaching can include squeezing or striking the fluid packet throughmaterial of the catheter container.

[0035] Moving the container to wet the catheter can be accomplishedthrough typical ways in the which a person moves or manipulates a smallcontainer such as a catheter container. For example, moving thecontainer can include tilting or rotating one end of the cathetercontainer relative to its other end, manipulating the catheter containerto move the water, or both moving and manipulating the container. Forexample, manipulating the container can include applying finger pressureto material forming the catheter container to push fluid within thecatheter container. Preferably, moving the catheter container achievesmoving the fluid over the insertable coated length of the hydrophiliccatheter. Moving the catheter container can be conducted over a periodof time sufficient to repeatedly contact each portion of the insertablelength of the catheter. In that way, the insertable length can becontacted for a sufficient time to completely wet the catheter.Preferably, breaching the fluid packet and moving the container areconducted without opening the catheter container.

[0036] The method can also include other procedures relating tocatheters, particularly urinary catheters. For example, the method caninclude opening the catheter container, removing the wetted catheterfrom the opened container, and/or using the wetted and removed catheter.

[0037] Illustrated Embodiments

[0038]FIG. 1 schematically illustrates an embodiment of a wetting systemaccording to the present invention. The illustrated embodiment of thesystem includes catheter pouch 1, wettable catheter 2, and fluid sachet3.

[0039] Catheter pouch 1 defines a pouch interior 4 that containswettable catheter 2 and fluid sachet 3. Pouch interior 4 is bounded byseam 5. In an embodiment, catheter pouch 1 is composed of an opaque ortranslucent back sheet 6 and transparent cover sheet 7. Back sheet 6 canbe composed of a plastic polymer such as polyethylene, e.g., low densitypolyethylene. Cover sheet 7 can be composed of a plastic polymer such aspolyethylene, e.g., high density polyethylene. Back sheet 6 and coversheet 7 can be joined to form seam 5 by an adhesive, by a weld, or thelike. Seam 5, back sheet 6, and cover sheet 7 are preferably liquidtight. Back sheet 6 and cover sheet 7 are preferably permeable tosterilants such as ethylene oxide.

[0040] Wettable catheter 2 includes flared outlet 8, shaft 9, tip 10,and eyelet 11. Shaft 9 and tip 10 define a lumen (not shown) leadingfrom eyelet 11 to outlet 8. Tip 10 and a major portion of shaft 9 ofwettable catheter 2 are coated with a wettable coating (not shown).

[0041] Fluid sachet 3 defines a fluid chamber 12, which can containfluid for wetting wettable catheter 2. Fluid sachet 3 can containsterile water, sterile saline, or another fluid suitable for wettingwettable catheter 2. Fluid sachet 3 can be opened, for example, byapplying finger or hand pressure or by striking by hand or with a smallobject. Opening fluid sachet 3 releases substantially all of the fluidit contains into pouch interior 4 without completely wetting shaft 9 ofwettable catheter 2. In particular, release of fluid from fluid sachet 3only incompletely wets the wettable coating. Fluid sachet 3 can belocated at any position within pouch interior 4.

[0042] In an embodiment, fluid sachet 3 can be made from polyethyleneand aluminum foil. Each piece making up fluid sachet 3 can include alayer aluminum foil sandwiched between layers of polyethylene. Thepolyethylene is adhered to the aluminum foil.

[0043]FIG. 2 schematically illustrates an embodiment of the wettingsystem according to FIG. 1 in which fluid sachet 3 has been opened andfluid 14 has been released from fluid sachet 3. Substantially all offluid 14 has been released from the fluid sachet 3, but fluid 14 hasonly incompletely wetted shaft 9 of wettable catheter 2.

[0044]FIG. 3 schematically illustrates an embodiment of the wettingsystem according to FIGS. 1 and 2 in which catheter pouch 1 has beenrocked, manipulated, or otherwise moved to spread fluid 14 along asubstantial portion of shaft 9 of wettable catheter 2.

[0045] Segmented Catheter Pouch

[0046]FIG. 4 schematically illustrates an embodiment of the wettingsystem according to the present invention. The illustrated embodiment ofthe system includes catheter pouch 1, wettable catheter 2, and fluidsachet 3. In this embodiment, catheter pouch 1 is in the form ofsegmented catheter pouch 15. Segmented catheter pouch 15 is constructedsimilarly to catheter pouch 1 and includes the features of catheterpouch 1.

[0047] As illustrated in FIG. 4, segmented catheter pouch 15 includesone or more pouch dividers 16. In the illustrated embodiment, pouchdividers 16 come in pairs, each pair being configured to narrow catheterpouch 1 to divide catheter pouch 1 into two or more segments 17.Segmented catheter pouch 15 can include, for example, three pairs ofpouch dividers (FIG. 4). Alternatively, a single pouch divider 16 cannarrow catheter pouch 1 to divide catheter pouch 1 into two or moresegments 17, for example, by extending as the same distance acrosscatheter pouch 1 as a pair of pouch dividers 16. Typically, pouchdivider 16 is made up of back sheet 6 and cover sheet 7. Back sheet 6and cover sheet 7 can be joined to form pouch divider 16 by, forexample, an adhesive, a weld, or the like. Pouch divider 16 can be anextension of or protrusion from seam 5.

[0048] Segmented catheter pouch 15 can include two, three, four, or moresegments 17. Wettable catheter 2 can reside in a plurality of segments17. Fluid sachet 3 can reside in a single segment 17. In an embodiment,fluid sachet 3 resides in a segment 17 also occupied by tip 10 ofwettable catheter 2. In an embodiment, fluid sachet 3 resides in asegment 17 not occupied by tip 10 of wettable catheter 2. In anembodiment, fluid sachet 3 resides in a segment 17 also occupied byshaft 9 of wettable catheter 2. In an embodiment, fluid sachet 3 residesin a segment 17 also occupied by flared outlet 8 of wettable catheter 2.

[0049] Segment 17 of segmented catheter pouch 15 that contains fluidsachet 3 can be in the form of a sachet housing 18. Sachet housing 18 istypically of larger volume than other segments to provide space forhousing fluid sachet 3. Sachet housing 18 can, for example, can be madeup of back sheet 6 and cover sheet 7, with cover sheet defining a largervolume than it does in other segments 17. For example, back sheet 6 andcover sheet 7 can define a rectangular volume for sachet housing 18(FIG. 4).

[0050] Catheter pouch 1 or segmented catheter pouch 15 can include acatheter channel 19. Catheter channel 19 can, for example, can be madeup of back sheet 6 and cover sheet 7. Catheter channel 19 is dimensionedfor containing wettable catheter 2 and retaining fluid 14 near or oncatheter 2.

[0051]FIG. 5 schematically illustrates an embodiment of the wettingsystem according to FIG. 4 in which fluid sachet 3 has been opened andfluid 14 has been released from fluid sachet 3. Substantially all offluid 14 has been released from the fluid sachet 3, but fluid 14 hasonly incompletely wetted shaft 9 of wettable catheter 2. In anembodiment, pouch dividers 16 restrict the flow of fluid 14 in segmentedcatheter pouch 15. Pouch dividers 16 can also direct fluid towardwettable catheter 2 in segmented catheter pouch 15.

[0052]FIG. 6 schematically illustrates an embodiment of the wettingsystem according to FIGS. 4 and 5 in which segmented catheter pouch 15has been rocked, manipulated, or otherwise moved to spread fluid 14along a substantial portion of shaft 9 of wettable catheter 2.

[0053] It should be noted that, as used in this specification and theappended claims, the singular forms “a,” “an,” and “the” include pluralreferents unless the content clearly dictates otherwise. Thus, forexample, reference to an apparatus including “a widget” includes a anapparatus including two or more widgets. It should also be noted thatthe term “or” is generally employed in its sense including “and/or”unless the content clearly dictates otherwise.

[0054] It should also be noted that, as used in this specification andthe appended claims, the phrase “adapted and configured” describes asystem, apparatus, or other structure that is constructed or configuredto perform a particular task or adopt a particular configuration. Thephrase “adapted and configured” can be used interchangeably with othersimilar phrases such as arranged and configured, constructed andarranged, adapted, constructed, configured, manufactured and arranged,and the like.

[0055] The invention has been described with reference to variousspecific and preferred embodiments and techniques. However, it should beunderstood that many variations and modifications may be made whileremaining within the spirit and scope of the invention.

We claim:
 1. A catheter wetting system comprising: a catheter container;a fluid packet; and a hydrophilic catheter; the fluid packet and thehydrophilic catheter being sealed within the catheter container; thefluid packet and catheter container being adapted and configured so thatopening the packet only incompletely wets the coated length of thehydrophilic catheter.
 2. The catheter wetting system of claim 1, whereinthe catheter container is adapted and configured to be moved to movewetting fluid over the insertable coated length of the hydrophiliccatheter.
 3. The catheter wetting system of claim 1, wherein thecatheter container comprises flexible material that can be manipulatedto spread wetting fluid over the coated length of the hydrophiliccatheter.
 4. The catheter wetting system of claim 1, wherein thecatheter container comprises a pouch formed from a translucent materialand a clear material, a first side of the pouch comprising thetranslucent material and a second side of the pouch comprising the clearmaterial, the pouch being sealed around the edges.
 5. The catheterwetting system of claim 1, wherein the fluid packet comprises a firstpiece of packet material and a second piece of packet material, thefirst piece and second piece of packet material being sealed to oneanother around the edges, the seal being substantially uniform aroundthe edge.
 6. The catheter wetting system of claim 1, wherein the fluidpacket comprises hydrophobic material.
 7. The catheter wetting system ofclaim 6, wherein the hydrophobic material comprises polyethylene andaluminum foil.
 8. The catheter wetting system of claim 1, wherein thefluid packet comprises an aqueous wetting composition.
 9. The catheterwetting system of claim 8, wherein the aqueous wetting compositioncomprises sterile water or sterile saline solution.
 10. The catheterwetting system of claim 8, wherein the sterile water or sterile salinesolution comprise sterile distilled water.
 11. The catheter wettingsystem of claim 1, wherein the hydrophilic catheter comprises ahydrophilic coating over an insertable length of the catheter.
 12. Thecatheter wetting system of claim 1, further comprising a urinecollection bag.
 13. The catheter wetting system of claim 1, furthercomprising instructions that the catheter container be moved to move thewetting fluid over the insertable coated length of the hydrophiliccatheter.
 14. The catheter wetting system of claim 1, further comprisinginstructions printed on the catheter container stating that the cathetercontainer be moved to move the wetting fluid over the insertable coatedlength of the hydrophilic catheter.
 15. A method of wetting ahydrophilic catheter comprising: providing a hydrophilic catheter and afluid packet in a catheter container; breaching the fluid packet torelease fluid into the container thereby only incompletely wetting thecoated length of the hydrophilic catheter; and moving the container tomove the wetting fluid over the insertable coated length of thehydrophilic catheter.
 16. The method of claim 15, wherein providingcomprises providing a catheter container with the hydrophilic catheterand the fluid packet sealed inside.
 17. The method of claim 15, whereinbreaching comprises striking, piercing, or squeezing the fluid packet.18. The method of claim 17, wherein breaching comprises squeezing orstriking the fluid packet without opening the catheter container. 19.The method of claim 17, wherein breaching comprises squeezing orstriking the fluid packet through material of the catheter container.20. The method of claim 15, wherein moving comprises tilting one end ofthe catheter container relative to an opposite end of the cathetercontainer, manipulating the catheter container to move the water, orboth tilting and manipulating.
 21. The method of claim 15, whereinmanipulating the catheter container comprises applying finger pressureto material forming the catheter container to push fluid within thecatheter container.
 22. The method of claim 15, further comprising:opening the catheter container; removing the wetted hydrophilic catheterfrom the opened catheter container; and using the wetted and removedhydrophilic catheter.
 23. The method of claim 15, wherein breaching andmoving are conducted without opening the catheter container.
 24. Anarticle of manufacture comprising: a catheter container; a fluid packet;a hydrophilic catheter; and instructions that the catheter container bemoved to move the wetting fluid over the insertable coated length of thehydrophilic catheter; the fluid packet and the hydrophilic catheterbeing sealed within the catheter container; the fluid packet andcatheter container being adapted and configured so that opening thepacket wets only incompletely wets the coated length of the hydrophiliccatheter.
 25. The catheter wetting system of claim 24, comprising theinstructions printed on the catheter container or adhered to thecatheter container.